Job Summary

• Compile annual product quality reviews (APQRs) per applicable SOP’s
• Collect, analyse and summarize product review data correctly and completely in timely manner.

Job Responsibilities

• Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP:
  • Manufacturing Process Overview
  • Batches Released / Rejected
  • APIs, Excipients
  • Changes
  • Test Method and Specification

• Manufacturing / Process Validation, Equipment and Utilities Qualification
• Sterility Validation / Qualification (If applicable)
• Packaging Component Deviations/Changes
• Compendial Review
• Deviations
• Critical In-Process Attributes
• Analytical Test Results
• Recalls and Field Alerts, Returns
• Retention Samples Review
• Technical Agreements (as appropriate)
• Marketing Authorizations Variations and Post Market Commitments (as appropriate)
• Complaints
• Stability
• Conclusion and Product Rating
• Concerns, Recommendations and Issues for Follow-Up

• Perform complete and correct transactions of the data as per SOP / WI’s.
• Summarize and trend analytical data from LIMS or other acceptable systems.
• Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
• Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects.
• Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
• Responses to Project Leader’s queries for APQR summary reports as required.
• Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • B.Pharm/ M.Sc./ M. Pharm.

• Knowledge, Skills and Abilities
  • Excellent technical writing, communication skills and interpersonal skills.
  • Have the Good Academic Record from 10th Class Onwards.
  • Demonstrated cGMP knowledge.
  • Maintain the tracking system for compilation and review of assigned APQRs
  • Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
  • Perform all work in support of the Corporate values
• Experience
  • Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance.